目的 观察清咳平喘颗粒联合西医常规治疗成人社区获得性肺炎（community acquired pneumonia，CAP）痰热壅肺证患者的疗效和安全性。方法 采用多中心、随机双盲、安慰剂平行对照临床试验设计，纳入成人CAP痰热壅肺证患者80例，按1∶1比例随机分为治疗组和对照组，在西医常规治疗基础上，治疗组给予清咳平喘颗粒，对照组给予清咳平喘颗粒模拟剂，两组疗程均为10 d。观察两组患者的临床疗效，比较两组患者治疗前后肺炎影像学吸收评价得分、咳嗽和咳痰症状消失的患者比例和时间、咳嗽和咳痰评估问卷（cough and sputum assessment questionnaire，CASA-Q）、CURB-65（confusion, urea, respiratory rate blood pressure, age 65）评分、血白细胞计数、中性粒细胞百分比、C反应蛋白、抗感染治疗天数及不良事件发生率的差异。结果 治疗后，治疗组的总有效率为94.87%，明显高于对照组的74.36%，具有统计学意义（P＜0.05）。治疗后，两组患者肺炎影像学吸收评分较治疗前明显降低（P＜0.05）；但两组患者肺炎影像学吸收评分和肺炎总吸收率的差异无统计学意义（P＞0.05）；针对咳痰严重程度进行亚组分析，治疗组中重度咳痰患者的肺炎影像学吸收评分明显低于对照组（P＜0.05）。治疗组平均抗感染治疗天数、咳痰症状消失时间均短于对照组（P＜0.05）。治疗后，两组患者CASA-Q评分较治疗前显著升高、血炎症指标显著降低（P＜0.05）；但两组咳嗽症状消失时间、CASA-Q评分、CURB-65评分、血炎症指标比较，差异均无统计学意义（P＞0.05）。试验期间未发生严重不良事件，两组不良事件发生率无差异。结论 在西医常规治疗基础上，清咳平喘颗粒能有效减少CAP抗感染治疗天数，改善咳痰症状，缩短咳痰症状消失时间，且安全性良好。

Objective To observe the efficacy and safety of Qingke Pingchuan Granule (清咳平喘颗粒) combined with conventional western medicine in the treatment of adult community acquired pneumonia (CAP) with phlegm heat obstructing lung syndrome. Methods A multicenter, randomized, double-blind, placebos parallel controlled clinical trial was designed. A total of 80 cases of adult patients with CAP syndrome of sputum heat obstructing lung were randomly divided into treatment group and control group according to the ratio of 1:1. On the basis of conventional western medicine treatment, the treatment group was given Qingke Pingchuan Granule and the control group was given Qingke Pingchuan Granule simulator. The course of treatment for both groups was 10 days. The clinical efficacy of the two groups of patients was observed, and the score of pneumonia imaging absorption evaluation before and after treatment, the proportion and time of patients with cough and sputum symptoms disappearing, and the cough and sputum assessment questionnaire were compared between the two groups. Differences in CASA-Q, CURB-65 (confusion, urea, respiratory rate blood pressure, age 65) score, blood white blood cell count, neutrophil percentage, C-reactive protein, anti-infective treatment days and incidence of adverse events. Results After treatment, the total effective rate of the treatment group was 94.87%, which was significantly higher than that of the control group (74.36%), and the difference was statistically significant (P < 0.05). After treatment, the pneumonia imaging absorption scores in two groups were significantly lower than before treatment (P < 0.05). However, there was no significant difference in imaging absorption score and total absorption rate between the two groups (P > 0.05). According to the subgroup analysis of the severity of expectoration, the imaging absorption score of patients with moderate and severe expectoration in the treatment group was significantly lower than that in the control group (P < 0.05). The average anti-infective treatment days and the disappearance time of expectoration symptoms in the treatment group were shorter than those in the control group (P < 0.05). After treatment, CASA-Q score was significantly increased and blood inflammation index was significantly decreased in two groups compared with before treatment (P < 0.05); However, there were no significant differences in the disappearance time of cough symptoms, CASA-Q score, CURB-65 score and blood inflammation indexes between the two groups (P > 0.05). In terms of safety, no serious adverse events occurred during the trial, and the incidence of adverse events was not different between the two groups. Conclusion On the basis of conventional western medicine treatment, Qingke Pingchuan Granules can effectively reduce the days of anti-infection treatment, improve the symptoms of expectoration, shorten the time of disappearance of expectoration symptoms, and have good safety.

R285.64

广东省科技厅省企联合基金-重点项目（2022B1515230001）；广州市中医药防治慢性咳喘病重点实验室项目（2023A03J0226）；广东省中医药局林琳省名中医传承工作室（粤中医办函[2023]108号）；广东省中医院周仲瑛学术经验传承工作室建设项目（中医二院[2014]89号）；广州中医药大学“双一流”与高水平大学学科协同创新团队项目（2021xk27）；中国民族医药学会科研项目（2021Z2144-540102）